Generalized Anxiety DisorderPhase 2CEASE-GADNCT07330648
Prospective Clinical Trial of Crisugabalin Capsules in the Treatment of Generalized Anxiety Disorder
A Phase 2 study testing Crisugabalin 20mg bid, Venlafaxine-XR 75mg bid and Crisugabalin capsules mimic 0mg/capsule bid in people with Generalized Anxiety Disorder, run by Anhui Medical University at 1 site in China.
Trial summary
A placebo-controlled superiority design was used to evaluate the efficacy of 40 mg/ day of Crisugabalin capsules in the treatment of GAD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Crisugabalin 20mg bid, Venlafaxine-XR 75mg bid and Crisugabalin capsules mimic 0mg/capsule bid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2025to 28 Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and voluntarily participate in the trial, and provide written informed consent form (ICF);
- Male or female aged ≥18 years (inclusive of the threshold value);
- Met the diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for generalized anxiety disorder (GAD) and confirmed by the Brief International Neuropsychiatric Interview (M.I.N.I.);
- Require pharmacological treatment for psychiatric symptoms;
- Hamilton Anxiety Scale (HAMA) score ≥20, Hamilton Depression Scale (HAMD-17) score ≤2, Clinical Global Impression Scale (CGI-S) score ≥4 at screening and baseline Points;
Who cannot join
- subjects with serious suicide risk at present, or HAMD-17 item 3-suicide score ≥3;
- subjects with HAMD-17 > 17;
- subjects whose HAMA scores decreased by ≥20% in the baseline period compared with the screening period:
- Those who met the DSM-5 diagnostic criteria for other mental disorders except GAD;
- subjects with previous history of depression, obsessive-compulsive disorder, bipolar disorder, psychotic disorder, factitious disorder and somatoform disorder; There were severe personality disorders, especially antisocial, borderline, or histrionic personality disorder, which were judged by the investigator to affect the patient's adherence to the study protocol;
- Alcohol or drug abuse or dependence within 180 days before screening;
Show all 24Show fewer
- With severe or unstable has clinical significance of somatic disease, including any cardiovascular, cancer, kidney, respiratory, endocrine (including abnormal thyroid function), digestion, blood (such as with bleeding tendency) or nervous system diseases;
- History of inadequate response to at least two prior antidepressant drugs and/or benzodiazepines after adequate dose and duration of treatment (i.e., at least 4 weeks at a clinically appropriate dose), or failure to achieve sufficient clinical efficacy with pregabalin ≥300 mg/day (i.e., subject-reported insufficient response or lack of meaningful clinical improvement).
- History of severe hypersensitivity reactions (e.g., anaphylaxis) or allergies to at least two classes of drugs (including photosensitivity), or known hypersensitivity to pregabalin, the investigational drug, structurally related compounds, or any of their excipients.
- subjects whose physical examination or vital signs were abnormal and clinically significant (e.g. inadequately controlled hypertension, systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg);
- subjects with a history of epilepsy or any other disease that may induce seizures, except convulsions caused by febrile convulsions in children;
- Severe hematologic, hepatic or renal dysfunction during the screening period, the subject will be excluded if: a. Neutrophils < 1.5 × 10^9/L, or platelet < 90 × 10^9/L, or hemoglobin < 100 g/L; b. AST/ALT > 2.5 × upper limit of normal (ULN), or TBIL > 1.5 × ULN; c. Estimation of glomerular filtration rate (eGFR) < 60 mL/min / 1.73 m^2; d. Creatine kinase > 2.0 × ULN.
- Clinically significant abnormalities on electrocardiography (QT interval corrected by Fridericia method: ≥450 ms for men or ≥470 ms for women) or conditions deemed ineligible by the investigators;
- Subjects who had undergone psychiatric surgery, electroconvulsive therapy or transcranial magnetic stimulation within 90 days before screening;
- Use of β-blockers within 90 days prior to screening with an ongoing need for continued treatment;
- Receiving systemic psychotherapy or other non-pharmacological treatments (e.g., acupuncture, hypnosis, or phototherapy) within 6 weeks before the baseline visit;
- Subjects with dysphagia or inability to tolerate oral medications.
- Subjects with active gastrointestinal disorders (including any history of gastrointestinal surgery) that, in the investigator's judgment, may interfere with the absorption of the investigational drug.
- Those who had used benzodiazepines within -7 to -1 days before screening, such as lorazepam, oxazepam, and alprazolam for less than 5 half-lives; The use of benzodiazepines with longer half-lives, such as diazepam, clonazepam, nitrazepam, estazolam, and flurazepam, not more than 5 half-lives or less than 30 days from the screening period, or the use of barbiturates not more than 5 half-lives or less than 30 days from the screening period;
- Patients who discontinued traditional Chinese medicine, melatonin, and St. John's wort for less than 3 days before the baseline visit;
- Pregnant or preparing for pregnancy or breastfeeding during the study period, or subjects were not willing to use reliable contraceptives methods from the date of ICF signature until 28 days after the last trial drug administration, or planning to use progesterone contraceptives during this period;
- Individuals engaged in potentially hazardous mechanical operations such as working at heights or operating motor vehicles.
- Participants enrolled in other clinical trials within 30 days before screening;
- Subjects with other conditions deemed by the investigator to be ineligible for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000
Kai Wang, +8613805512494, wangkai1964@126.com
About this study
Official title: Evaluation of the Efficacy and Safety of Crisugabalin Capsules Versus Placebo and Venlafaxine Extended-Release (XR) Capsules in Chinese Patients With Generalized Anxiety Disorder: A Prospective, Multicenter, Randomized, Double-Blind, Double-Dummy, Active- and Placebo-Controlled Clinical Trial.
A placebo-controlled superiority design was used to evaluate the efficacy of 40 mg/ day of Crisugabalin capsules in the treatment of GAD.
Read the detailed description
This was a prospective, multicenter, randomized, double-blind, double-dummy, active- and placebo-controlled clinical trial.
Qualified subjects, according to the ratio of 1:1:1, were randomized into Crisugabalin group, Venlafaxine-control group and placebo-control group, and received a double-blind treatment course of 8 weeks. After completing the 8-week double-blind treatment period, subjects will officially conclude the study or voluntarily enter a 4-week open-label extension treatment phase. During the open-label extension phase, all subjects will receive Crisugabalin 80 mg/day (40 mg bid). Participants were followed from baseline outpatient visit until end of the follow-up period (14 weeks and 9 visits in total).
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Crisugabalin 20mg bid, Venlafaxine-XR 75mg bid, Crisugabalin capsules mimic 0mg/capsule bid
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crisugabalin 20mg bidDrug
Also called HSK16149
Crisugabalin 20mg bid Crisugabalin 20mg, orally twice a day; treatment period: 8 weeks fixed dose. Open-label extension phase: Crisugabalin 40mg, orally twice a day; treatment period: 4 weeks fixed dose.
Venlafaxine-XR 75mg bidDrug
Also called Venlafaxine-XR
Venlafaxine-XR 75mg bid Venlafaxine-XR 75mg, orally once a day and the second dose of placebo was administered; treatment period: 8 weeks fixed dose.
Crisugabalin capsules mimic 0mg/capsule bidDrug
Also called Crisugabalin capsules mimic, Venlafaxine-XR capsules mimic
Crisugabalin capsules mimic 0mg/capsule, orally twice a day; treatment period: 8 weeks fixed dose.
Drug: Venlafaxine-XR capsules mimic, 0mg/capsule, bid Drug: Venlafaxine-XR capsules mimic, 0mg/capsule, bid Venlafaxine-XR capsules mimic, 0mg/capsule, orally twice a day; treatment period: 8 weeks fixed dose.
| Study group | Role | What they receive |
|---|---|---|
| Crisugabalin 80mg/day group | Experimental | Crisugabalin 20mg, orally twice a day; treatment period: 8 weeks fixed dose. Open-label extension phase: Crisugabalin 40mg, orally twice a day; treatment period: 4 weeks fixed dose. Receives: Drug: Crisugabalin 20mg bid |
| Venlafaxine Extended-Release (XR) Capsules 150mg/day group | Experimental | Drug: Venlafaxine-XR 75mg bid Venlafaxine-XR 75mg, orally once a day and the second dose of placebo was administered; treatment period: 8 weeks fixed dose. Receives: Drug: Venlafaxine-XR 75mg bid |
| Placebo-Control group | Placebo comparator | Drug: Crisugabalin capsules mimic 0mg/capsule bid Crisugabalin capsules mimic 0mg/capsule, orally twice a day; treatment period: 8 weeks fixed dose.
Drug: Venlafaxine-XR capsules mimic, 0mg/capsule, bid Venlafaxine-XR capsules mimic, 0mg/capsule, orally twice a day; treatment period: 8 weeks fixed dose. Receives: Drug: Crisugabalin capsules mimic 0mg/capsule bid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Anxiety (HAMA) scale score after 8 week treatment
The Hamilton Anxiety (HAMA) scale score reflects the severity of the subjects anxiety symptoms. The primary efficacy end point was the change from baseline to week 8 in HAMA total score to determine the superiority of crisugabalin capsules over placebo. The larger the difference between crisugabalin capsules over placebo, the better the curative effect.The HAMA consists of 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Measured: from baseline to week 8
Secondary outcomes (7)
Change in Hamilton anxiety scale score after treatment
One of the secondary efficacy end point was the change from baseline to week 8 in Hamilton anxiety scale to determine the superiority of crisugabalin capsules over placebo. The larger the difference between crisugabalin capsules over placebo, the better the curative effect.The HAMA consists of 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Measured: from baseline to week 8
Change in each factor score and item score of Hamilton anxiety scale
One of the secondary efficacy end point was the change from baseline to week 8 in each factor score and item score of Hamilton anxiety scale to determine the superiority of crisugabalin capsules over placebo. The larger the difference between crisugabalin capsules over placebo, the better the curative effect. The HAMA consists of 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Measured: from baseline to week 8
Clinical global impression of improvement score
Subjective improvement of crisugabalin capsules will be assessed using Clinical Global Impression of Improvement (CGI-I) score at week 4 and 8. The larger the difference between crisugabalin capsules over placebo, the better the curative effect. The CGI-I scale is used to measure the clinician's assessment of how much the participant's illness has improved or worsened relative to baseline. The CGI-I comprises one item with 7 possible ratings (1-7 points), where a lower score indicates improvement, and a higher score indicates worsening.
Measured: the end of week 4 and 8
Clinical global impression of severity score
Subjective severity of crisugabalin capsules will be assessed by the change from baseline to week 4 and 8 with Clinical global impression of severity (CGI-S) score, to determine the superiority of crisugabalin capsules over placebo. The larger the difference between crisugabalin capsules over placebo, the better the curative effect. The CGI-S scale assesses the clinician's impression of the participant's current severity of illness relative to the clinician's experience with patients who have the same diagnosis. The CGI-S comprises one item with 7 possible ratings (1-7 points), where a higher score indicates more severe illness.
Measured: the end of week 4 and 8
Complete remission rate
Complete remission rate was the proportion of subjects with HAMA total scale score ≤7 at the end of week 8. The larger the difference between crisugabalin capsules over placebo, the better the curative effect. The HAMA consists of 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Measured: the end of week 8
Response rate
Response rate was the proportion of subjects with HAMA total score decreased by ≥50% from baseline to week 8. The larger the difference between crisugabalin capsules over placebo, the better the curative effect. The HAMA consists of 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Measured: the end of week 8
Rapid-onset rate
Rapid-onset rate was the proportion of subjects with HAMA total score decreased by ≥20% from baseline to week 1 and 2. The larger the difference between crisugabalin capsules over placebo, the better the curative effect. The HAMA consists of 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Measured: the end of week 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start10 Oct 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WANG KAI, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330648
- Sponsor's protocol ID
- HSK16149-502
- Acronym
- CEASE-GAD
- Status last verified
- Oct 2025
- First submitted
- 24 Nov 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Crisugabalin Capsules Versus Placebo and Venlafaxine Extended-Release (XR) Capsules in Chinese Patients With Generalized Anxiety Disorder: A Prospective, Multicenter, Randomized, Double-Blind, Double-Dummy, Active- and Placebo-Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT07330648
- Acronym / sponsor ID
- CEASE-GAD / HSK16149-502
- Conditions
- Generalized Anxiety Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A placebo-controlled superiority design was used to evaluate the efficacy of 40 mg/ day of Crisugabalin capsules in the treatment of GAD.
Detailed description
This was a prospective, multicenter, randomized, double-blind, double-dummy, active- and placebo-controlled clinical trial.
Qualified subjects, according to the ratio of 1:1:1, were randomized into Crisugabalin group, Venlafaxine-control group and placebo-control group, and received a double-blind treatment course of 8 weeks. After completing the 8-week double-blind treatment period, subjects will officially conclude the study or voluntarily enter a 4-week open-label extension treatment phase. During the open-label extension phase, all subjects will receive Crisugabalin 80 mg/day (40 mg bid). Participants were followed from baseline outpatient visit until end of the follow-up period (14 weeks and 9 visits in total).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Crisugabalin 80mg/day group | Experimental | Drug: Crisugabalin 20mg bidCrisugabalin 20mg, orally twice a day; treatment period: 8 weeks fixed dose. Open-label extension phase: Crisugabalin 40mg, orally twice a day; treatment period: 4 weeks fixed dose. |
| Venlafaxine Extended-Release (XR) Capsules 150mg/day group | Experimental | Drug: Venlafaxine-XR 75mg bidDrug: Venlafaxine-XR 75mg bid Venlafaxine-XR 75mg, orally once a day and the second dose of placebo was administered; treatment period: 8 weeks fixed dose. |
| Placebo-Control group | Placebo comparator | Drug: Crisugabalin capsules mimic 0mg/capsule bidDrug: Crisugabalin capsules mimic 0mg/capsule bid Crisugabalin capsules mimic 0mg/capsule, orally twice a day; treatment period: 8 weeks fixed dose. Drug: Venlafaxine-XR capsules mimic, 0mg/capsule, bid Venlafaxine-XR capsules mimic, 0mg/capsule, orally twice a day; treatment period: 8 weeks fixed dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to understand and voluntarily participate in the trial, and provide written informed consent form (ICF);
- Male or female aged ≥18 years (inclusive of the threshold value);
- Met the diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for generalized anxiety disorder (GAD) and confirmed by the Brief International Neuropsychiatric Interview (M.I.N.I.);
- Require pharmacological treatment for psychiatric symptoms;
- Hamilton Anxiety Scale (HAMA) score ≥20, Hamilton Depression Scale (HAMD-17) score ≤2, Clinical Global Impression Scale (CGI-S) score ≥4 at screening and baseline Points;
Key exclusion criteria (24 listed)
- subjects with serious suicide risk at present, or HAMD-17 item 3-suicide score ≥3;
- subjects with HAMD-17 > 17;
- subjects whose HAMA scores decreased by ≥20% in the baseline period compared with the screening period:
- Those who met the DSM-5 diagnostic criteria for other mental disorders except GAD;
- subjects with previous history of depression, obsessive-compulsive disorder, bipolar disorder, psychotic disorder, factitious disorder and somatoform disorder; There were severe personality disorders, especially antisocial, borderline, or histrionic personality disorder, which were judged by the investigator to affect the patient's adherence to the study protocol;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crisugabalin 20mg bidAlso: HSK16149Crisugabalin 20mg bid Crisugabalin 20mg, orally twice a day; treatment period: 8 weeks fixed dose. Open-label extension phase: Crisugabalin 40mg, orally twice a day; treatment period: 4 weeks fixed dose. | Drug | Crisugabalin 80mg/day group |
| Venlafaxine-XR 75mg bidAlso: Venlafaxine-XRVenlafaxine-XR 75mg bid Venlafaxine-XR 75mg, orally once a day and the second dose of placebo was administered; treatment period: 8 weeks fixed dose. | Drug | Venlafaxine Extended-Release (XR) Capsules 150mg/day group |
| Crisugabalin capsules mimic 0mg/capsule bidAlso: Crisugabalin capsules mimic, Venlafaxine-XR capsules mimicCrisugabalin capsules mimic 0mg/capsule, orally twice a day; treatment period: 8 weeks fixed dose. Drug: Venlafaxine-XR capsules mimic, 0mg/capsule, bid Drug: Venlafaxine-XR capsules mimic, 0mg/capsule, bid Venlafaxine-XR capsules mimic, 0mg/capsule, orally twice a day; treatment period: 8 weeks fixed dose. | Drug | Placebo-Control group |
Primary outcome
Change in Hamilton Anxiety (HAMA) scale score after 8 week treatment
Time frame: from baseline to week 8
The Hamilton Anxiety (HAMA) scale score reflects the severity of the subjects anxiety symptoms. The primary efficacy end point was the change from baseline to week 8 in HAMA total score to determine the superiority of crisugabalin capsules over placebo. The larger the difference between crisugabalin capsules over placebo, the better the curative effect.The HAMA consists of 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
7 secondary outcomes
Change in Hamilton anxiety scale score after treatment
Time frame: from baseline to week 8
Change in each factor score and item score of Hamilton anxiety scale
Time frame: from baseline to week 8
Clinical global impression of improvement score
Time frame: the end of week 4 and 8
Clinical global impression of severity score
Time frame: the end of week 4 and 8
Complete remission rate
Time frame: the end of week 8
Response rate
Time frame: the end of week 8
Rapid-onset rate
Time frame: the end of week 1 and 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Crisugabalin 20mg bid, Venlafaxine-XR 75mg bid and Crisugabalin capsules mimic 0mg/capsule bid in people with Generalized Anxiety Disorder, run by Anhui Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai Wang (+8613805512494, wangkai1964@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hamilton Anxiety (HAMA) scale score after 8 week treatment (time frame: from baseline to week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.